The Daily Beast has published what I can only describe as a hack job on the quest of the oral contraceptive pill (OCP) to go over-the-counter OTC). The piece opines that it isn’t safe for women to take OCPs without a prescription from a doctor and intimates that a lot of women are at risk for blood clots.

The reporter, Sarah Watts, doesn’t quote any published research on OCPs going OTC although there is plenty, after all the idea has been kicking around for 20-25 years and has stalled due to politics not medicine. Instead, the article rests heavily on the opinion of Dr. Poppy Daniels, an OB/GYN in Springfield, MO (who hasn’t published any work on the birth control pill that I can find in PubMed), and the views of Holly Grigg-Spall, a woman who tried four or five different pills and then wrote a book about how the pill is really a tool of the patriarchy, addictive, and we should all just be able to work when our cycle says we are most productive. I think. I found her arguments poorly constructed and difficult to follow and felt the medical information, such as it was, was grossly mishandled. If you want to know more about her book read this review from Slate that calls it, “poorly researched, shoddily argued, and fundamentally incoherent.”

However, unlike the reporter for the Daily Beast I know how to contact published experts in the field, search PubMed, and read articles and consensus opinions so let’s take down the piece point by point.

Problem #1: The assertion that blood clotting disorders are extremely common, thus the pill is very dangerous for many women

According to Dr. Daniels, “blood-clotting disorders are extremely common, and are typically related to a gene mutation that affects an estimated forty percent of the population.”

The link goes to a Daily Beast piece on the MTHFR mutation. The geneticist I spoke with (so an expert in the area) says an MTHFR mutation affects 25% of the population not 40% and is almost never associated with clotting issues.

According to the genetics home reference library the link between clotting disorders or high blood pressure and MTHFR is controversial and it remains “unclear what role changes in the MTHFR gene play in these disorders.”

According to Dr. Daniel Grossman MD, one of the leading experts in the field, if 100,000 women use the pill (one of the older pills or what we call 2nd generation pills) for a year 12.5 will have a clot. So if 40% of women were truly at high risk for clotting on the pill, considering how many women actually take the pill we would have known years ago – basically that number would be a lot higher than 12.5.

Problem #2 – The idea that women need special screening for the pill, screening that only a doctor can do

Dr. Daniels only prescribes “hormonal contraception—including the pill, the patch, or the NuvaRing—after she has carefully evaluated the risks for each patient, including a rundown of the patient’s family history for blood clots, strokes, and heart attacks.”

Science tells us that she is wrong and if the Daily Beast wanted to be accurate they would have told their readers that flipping a coin is about as good as asking about risk based on family history.A meta-analysis from 2012 looked that this very question.I read the article when it came out, but here’s a tidy summary from the abstract:

Obtaining a family history of venous thromboembolism before starting combined oral contraceptives is not a valid means to detect a woman’s risk of thrombophilia. Even in high-prevalence populations, in which the positive predictive value is increased, a positive family history of venous thromboembolism was no better than flipping a coin in predicting thrombophilia.

I even spoke with the lead author personally, Dr. David Grimes, to confirm this. He has written 42 articles on the oral contraceptive pill so he’s got this covered.

Dr. Grossman agreed that the only screening needed is “measuring blood pressure and asking about personal medical history.” Grossman also wrote to me that “having a family history of someone having a deep venous thrombosis is not a contraindication.”

Problem #3 The idea OTC medications are much safer than the pill

According to Dr. Daniels “To put [hormonal contraception] on the same aisle as Tylenol and Zantac is absurd.”

Acetaminophen and many OTC medications can be quite toxic if used incorrectly. In the UK the amount of acetaminophen one can buy in a pack is severelylimited for one reason –safety. It kills people and causes liver failure much more often than you think.If women can be trusted to take Tylenol or Advil or Aspirin in the United States they can be trusted to take the pill.

Routine screening for factor V Leiden in asymptomatic women contemplating or using oral contraceptives is not recommended, except for those with a personal history of thromboembolism or other medical risk factors.

(The American College of Medical Genetics being the experts).

Hey Daily Beast, why the fear mongering?

Confirmation bias? Slow day in the news room? A press release from Ricky Lake’s new movie burning a hole in your in box?

There is no medical controversy about OCPs going OTC. At all. All you need is a blood pressure check and a check list for some specific medical contraindications (like you find on many medications you can buy over the counter).

Want to know if you can safely take the pill? Download this free app from the CDC and you can search by condition and method of contraception. If you are over 35 and smoke, you can’t take the pill with estrogen. When it comes to the birth control pill without estrogen (the progestin only pill) there is essentially no contraindication at all.

The Daily Beast should retract this piece. It is devoid of science and it is the very definition of patriarchy to suggest that a woman can’t read a package insert and get her blood pressure checked at a pharmacy before picking up her pills.

****

Due to the high number of personal attacks I would like to restate my commenting policy. Don’t make personal attacks. Really. If you want to counter the science with links to research, please do so. If you want to express your opinion, please do so. If you want to comment on what I wrote, fine. But personal attacks will not be approved.

Discussion

They act like women have no sense!!! If that is the case why don’t they make women line up every day for their daily OCP – wouldn’t want them to take all those little pills in the fancy container all at once. The whole thing is crazy and boggles the mind!!!!!!

You seem to have misunderstood ‘Sweetening The Pill’. The work of Grigg-Spall and others like her focuses on social aspects of hormonal contraception that influence how it is used (e.g. the myth that it ‘regulate periods’), concerns of doctors using hormonal contraception as a band-aid for any and all women’s health problems from menarche onwards (how doctors use false information or bully patients onto such methods, as well as how this means many go without treatment for more serious underlying issues or take hormonal contraception when unneeded), and how women’s bad experiences with side-effects or the risks are overlooked or misrepresented. The main themes are coercion/lack of educated choice and medicalization of the female body.

There is all kinds of research on how the pill is used, why women stop it, and the true complication and side effect rates. If you are writing on the subject, you need data not just a collection of postings from Internet message boards.

Hi Jen – thanks for this article. I agree that the BCP is probably a safe choice for most women and making it over-the-counter is reasonably safe. What I wanted to explore are the potential downsides to a reasonably safe choice — no medical treatment is totally devoid of risk, as I’m sure you know. The takeaway from the article, I hope, is that perhaps *some women* need to consult with their doctors to make sure the risks outweigh the benefits *for their particular circumstance.* Is it really the “definition of patriarchy” to suggest that some women need to consult with their doctor before taking a medication? I think that’s a stretch.

In addition to Dr. Daniels, I have spoken to a geneticist and MTHFR specialist who, along with Daniels, has told me that clotting disorders are a very common side-effect of MTHFR in their practice. The literature says that an estimated forty percent of the population has some form of the MTHFR defect — that doesn’t mean that 40 percent of women will have a blood clot, but the geneticists I spoke with said that blood clots are a very typical occurrence. I think it makes sense for there to be additional testing before the BCP is prescribed, considering that many women could be harboring a latent clotting disorder. It makes sense that hypothetically, a physician can provide better counseling than a pharmacist. I am not “against” taking the pill by any means — and I did make mention of the special interest groups who supported the pill, and their reasons why. I just think these are important questions that we need to consider carefully before making something widely available.

I don’t have a puritan belief system, and neither does Dr. Daniels, who prescribes the birth control pill often (with additional testing), and neither does Holly Grigg-Spall, who is secular, very pro-choice, and who is a strong proponent of nationalized healthcare. It’s disingenuous to claim that we do.

I quoted science and experts, you did not. 12.7 in 100,000 is not “some” women it is a rare occurrence. You also did not disclose that your only expert is a member of the American Association of Pro-Life OB/GYNs and their statements on most contraceptives are not supported by science. For example they claim the pill is an abortifacient.

Did you check out the linked Daily Beast article on MTHFR? It’s an astonishingly inaccurate piece by the same author about how folic acid could poison you, relying on quotes from a nutritionist (who thinks the mutations are more common in women – not sure how that could work) and a patient – no hematologists or geneticists to be found.

​How can an over the counter version of the pill be safe if the prescribed version of the pill is not safe for women in so many ways? (deadly pulmonary embolisms, stroke, heart attack; not to mention a depletion of essential vitamins and minerals, depression, anxiety, unhealthy weight gain, loss of libido, hair loss, infertility issues etc.) Why would any woman play “Russian Roulette” with her health by taking these drugs (yes, birth control pills are powerful drugs) when there are safe and effective alternatives to try first? I am a big proponent of birth control but think the safest alternatives should be tried FIRST. Making these drugs available over the counter for women only encourages women to take them without knowing all the facts about them. Not very smart in my opinion…please take a moment to read, highly respected, Dr. Kelly Brogan’s take on taking the pill:

I have read the book you refer to in your article, and believe this young woman has bravely stepped forward to provide women with information they may not otherwise be made aware of. Good for her!

I have removed the link to Kelly Brogan’s site as I don’t allow links to that kind of pseudoscience.

BTW Dr. Kelly Brogan is anti vaccine and believes the WHO is trying to sterilize women in Africa via vaccine programs. That is untrue and could hurt women and babies. If someone is highly respected they wouldn’t be promoting that kind of misinformation.

Dr. Kelly Brogan is a master of taking small snippets of research articles to make it seem like they support her anti-science views. When you read the complete articles, most often the research disagrees with her conclusion. Any research which disagrees with her pseudoscience is completely ignored.

In her most recent article on the pill and blood clots, she correctly noted, that the pill is a small risk factor for having blood clots. However, the authors of the research paper correctly said that the risk is much less than pregnancy, and the pill’s obviously helps prevent this dangerous state. Kelly Brogan forgot to mention this. Ooops.

Dr. Brogan used to be a real doctor, it seems, having worked at NYU and Bellevue. Now, she makes YouTube videos and movies telling other doctors how to do their jobs. Though she frequently claims credentials at NYU still, they don’t have any record of her (look for yourself.) She has not worked in a hospital in years, and seems to be an expert in telling other doctors what they are doing wrong, while conveniently seeing only rich patients who pay her cash in an expensive private office. It is only because she has no real responsibility for treating sick people that she can get about with her pseudoscience.

Interesting. I’ve prescribed alot of birth control pills over the years, always quoting the 1/10,000 risk of cloting but never checking for MTHFR defect (I’ve never even heard of this until today). Seems like another pro life ploy to keep contraception away from women who need it (which always seemed stupid to me; isn’t birth control better than an abortion??). In any case, my fear of OCPs becoming OTC is related to cost — from the perspective of an insured patient who mostly have $5-15 generic copays for a 3 month supply of OCPs (at least in TPMG), the cost of generic OTC OCPs could potentially far exceed this. This has occured with transdermal oxybutynin (Oxytrol) — previously a generic copay and now $20-25 per month. Do you see this as a potential issue?

I thought the readers of this blog might benefit from my question sent to you today in another blog Dr. Gunter (a blog regarding your opinion of Dr. Oz and his contributions to health awareness). Thank you, in advance, for your reply:

Taking a look into a few of the many blogs you have written, Dr. Gunter, which all seem to support Big Pharma and excoriate any ideas about promoting wellness as opposed to selling sickness, could you please provide your readers with a full disclosure of whether you have ever received any financial compensation and/or gifts from any Big Pharma corporation during your tenure as a physician? If you have not – good for you! If you have, it is only fair for your readers to be informed of this. Thank you.

Hi Jen. Holly Grigg-Spall here. It’s bizarre to me that you are focusing on my quotes, with no mention of Dr Poppy Daniels. I spoke with the writer for an hour, and she quoted me a couple of times. How she did this was not great, there’s a lot missing there. However, the quote you used here…well as you know I went on to argue FOR “full access and affordability” – ie. I actually think OTC birth control pills could be a great thing for women. I’ve said as much here: http://ladyclever.com/health-fitness/right-left-political-party-birth-control-agendas/ – in my own words – and elsewhere. My suggestion that women be screen for blood clots was made in the context of medical history – so therefore I also seem to be in agreement with you on that point. I went on to say to the writer that I thought pharmacists could do a great job of counseling women. So, your attack on me and my work, in this post, looks a little rash. The “problem” I was referring to is that of promoting the Pill in a way that is extremist – that is, not acknowledging there are problems that women do experience. That’s the context we’re in, at least in the US. As you know I am British and grew up with the NHS, I’m surprised you think I’d have a problem with access of any kind. I have a problem with the context – an issue you have deftly illustrated here.

She doesn’t seem to be the focus of the smear campaign conducted on Twitter this morning. Jen, you misquoted me, you deliberately did not include my statement on “full access and affordability” that’s in the piece in order to make your point. I am not comfortable with how you are misrepresenting my views here and elsewhere for your own agenda. Previously you have made defamatory statements publicly and here you are trying to suggest I am against access to hormonal contraceptives, which is not so. I want to redress that balance by saying here that I actually think OTC access could be great for women and by linking to my own piece on the topic. I know that probably doesn’t compute with your level of assumption at this time about me and my work, but I feel it’s important that your readers have full information.

I have a few questions for clarification in your article. One is that the 12.5 VTE rate for 100,000 women seemed low. My memory is that 1-2 per 10,000 women (10-20 per 100,000) would get a VTE without taking any hormonal birth control. I tried to find by a google search for a figure of 12.5 per 100,000 from Dr. Daniel Grossman MD, but could not. Could you point me to a source?

I am curious as the new study by Yana Vinogradova in the BMJ has all the rates for VTE at a much higher level. I believe this study measured 5 to 7 VTE per 10,000 for Levonorgestrel, which would be 50-70 per 100,000.

The other item is that you cited ” Homocystinuria affects 1/200,000 people in the United States ” and when I went to the website linked to your source, I found that they stated “The most common form of homocystinuria affects at least 1 in 200,000 to 335,000 people worldwide. The disorder appears to be more common in some countries, such as Ireland (1 in 65,000), Germany (1 in 17,800), Norway (1 in 6,400), and Qatar (1 in 1,800). The rarer forms of homocystinuria each have a small number of cases reported in the scientific literature.” I know they say that it appears to be more common in some countries, but given that many Americans have a genetic heritage/background from many of the countries with a higher rate, wouldn’t that put the rate higher here in the U.S?

Thanks, Jen. I’m more concerned that Aleve is sold OTC – I see no end of people with gastric irritation/ulcers/bleeding because none of them noticed the warnings that it is more than just a better Tylenol. I really do hate the drug industry, and the government that takes money from it to make such atrocities legal! The only objection to OTC BCPs would be the difficulty in making sure the purchaser understands exactly how to start them, how to take them and what to do if one is forgotten or late etc. The stuff that matters, as was impressed upon me when I did my Family Planning certificate back in the dark ages in the UK.

I could not agree more with you regarding your sentiments towards the drug industry. What about all of the terrible side effects of hormonal birth control pills…blood clots, pulmonary embolisms, strokes, depression, anxiety, weight gain, loss of libido, fertility issues etc…the “fine print” does not do an adequate job of informing women of these dangers, much less the symptoms they should be watching out for. Consider these comments made by women just today…

Alison 3:53pm Jun 19

One life lost is too much. After I read this page I stopped taking it. not worth the side effects. Makes me sad the ladies who not only died but have suffered from this evil ring.

Debra 3:44pm Jun 19

I have a client who had a 23 year old daughter that died from a blood clot from this crazy thing! Ladies beware do not use this❤️

Trish 10:57am Jun 19

Nuvaring caused a blood clot in my lung, it is very very bad

Alison 10:27am Jun 19

I went on it and was always in a rage. I called it Nuvarage. My legs started hurting and I found this page. After reading the stories, I took it out and never went back. Sad so many lives were lost. I have been off it for two years and don’t have the rage anymore or leg pain.

I am a family physician who regularly prescribes hormonal medications for contraception and for non-contraception reasons. I agree with your arguments on why these medications should be over the counter.

I think that the problem to overcome is the “community standard” argument.

Until a common sense approach is part of the community standard, we have an uphill climb.

I found your blog post via the RightCareWeekly digest sent out by the Lown Institute. They linked to your post.

I have become inspired by their mission to direct patient care toward what is best for the patient.

A common sense, evidence-based approach such as making OCPs OTC is part of that mission.